Purge factor assessment of toxic compounds (Genotoxic Impurities, Nitrosamine, and their precursors)

Our Purge Factor Assessment Service is designed to provide pharmaceutical manufacturers with a scientifically robust and regulatory-compliant strategy for the removal of genotoxic and nitrosamine impurities during the synthesis, work-up, and purification of Active Pharmaceutical Ingredients (APIs). 

By leveraging advanced computational tools and expert analysis, we ensure that your manufacturing process not only meets but exceeds regulatory requirements for impurity control.

What is Purge?

Purge refers to the systematic removal of impurities throughout the API manufacturing process. It is a critical step in ensuring the purity and safety of pharmaceutical products, aiming to reduce impurities to below acceptable limits without the need for direct testing.

Purge factor assessment of toxic compounds (Genotoxic Impurities, Nitrosamine, and Their precursors)

Traditional Technique vs. Veeprho Approach

  • Traditional Technique: Historically, synthetic chemists would assign purge scores based on their subjective understanding of the reactivity, solubility, and volatility of impurities.
  • Our Approach: We utilize a computer-assisted strategy that provides a reproducible, semi-quantitative measure for purge assessments. This method enhances consistency and confidence in impurity removal, aligned with current regulatory expectations.

Regulatory Requirements

Understanding and documenting the manufacturing process parameters and their impact on impurity purge is a regulatory necessity. Our service ensures that your process adheres to these requirements with comprehensive documentation to support regulatory submissions.

Advantages of Effective Purge Assessment

  • Reduced Testing Requirements: A satisfactory purge assessment can eliminate the need for extensive impurity testing, saving time and resources.
  • Cost-Effectiveness: Avoiding the costs associated with analytical testing, method development, and validation makes our purge assessment service a cost-effective solution.
  • Regulatory Compliance: Ensures that your manufacturing process meets global regulatory standards for impurity control.

Technical Information Required

To perform a thorough purge assessment, we require detailed information on the route of synthesis and work-up conditions during API manufacturing. This enables our experts to accurately evaluate and optimize the purge process.

Reproducibility and Support

  • Reproducibility: Our software-based assessments ensure consistent and reproducible results, unlike traditional methods that can vary significantly between individuals or labs.
  • Post-Assessment Support: We provide ongoing support for any regulatory queries related to your purge assessment, ensuring you have expert assistance when you need it.

Service Timeline

  • Rapid Assessment: With all necessary information provided, initial assessments can be completed in a few hours.
  • Comprehensive Review: For more complex processes, our experts may take 3-4 days to conduct a thorough review and provide a detailed assessment.

Our Deliverables

  • Final Assessment Report: Includes purge calculations, scientific rationale, and supporting evidence, along with expert commentary.
  • Regulatory Support Documentation: Tailored documents to aid in regulatory submissions and queries.

Our Approach

FeatureIn Silico (Mirabilis)Paper Based
ExpertiseConsortium of Industry ExpertsIndividual with Limited Knowledge
ApproachConservativeCould Be Arbitrary
AcceptabilityUniversally AcceptableCould Be Questionable
JustificationSupported with Literature EvidencesPerson-Specific Justification
DocumentationSelf Explanatory with All Supporting and Backup, Full Recall Without Person PresenceNeeds Person Presence for Explanation
Organizational Changes ImpactNo Impact Due to Organizational ChangesRisk Due to Organizational Change (Change in Job/Role and Retirement)
Industry ApproachCommon and Collaborative Approach of Top Pharma CompaniesCould Be Varied Approach
Data BaseFully Upgraded with Maximum Transformation/Process DatabaseCould Be Limited Database

Why Choose Computational Purge Assessment?

Our computational (In Silico) approach to purge assessment offers numerous advantages over traditional (Paper based) methods, including:

  • Industry Expert Consortium: Developed and supported by a consortium of industry experts, ensuring a broad and deep understanding of pharmaceutical processes and regulatory requirements.
  • Conservatism and Reliability: Our approach is conservative and universally acceptable, minimizing risk and ensuring compliance with global regulatory standards.
  • Evidence-Based Justification: Justifications for purge assessments are supported with extensive literature evidence, providing a solid foundation for regulatory submissions.
  • Self-Explanatory and Comprehensive: The assessment is self-explanatory, with all supporting documentation and backup, allowing for full recall of information without the need for the original analyst’s presence.
  • Stability Against Organizational Changes: Our methodology is not impacted by organizational changes, such as changes in job roles or retirement, ensuring continuity and consistency in your purge strategy.
  • Collaborative Industry Approach: Reflects a common and collaborative approach among top pharmaceutical companies, enhancing the credibility and acceptance of the assessment results.
  • Up-to-Date Database: Continuously upgraded with the maximum transformation/process data available, keeping your assessments current with industry standards and practices.

Contact Veeprho for Purge Factor Assessment of Toxic compounds

Ready to enhance your API manufacturing process with our Purge Factor Assessment Service? Contact us today to schedule a consultation or to learn more about how we can support your regulatory compliance and product safety goals.

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